Oncogenous HPV DNA Integration (Intégration De l'ADN Des HPV Oncogènes) (IDAHO)

June 11, 2020 updated by: CHU de Reims

Association Between High-risk HPV Genome Integration Detected by Molecular Combing and Cervical Lesions Severity and/or Evolution

High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development. Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical cancer development. The aim of this study is to validate the integration of the HPV-HR as an appropriate biomarker of the severity of precancerous lesions and progression of cervical lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular Combing technology, which allows direct and high-resolution visualization of the integration of high-risk HPV genomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

407

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU de Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women aged from 25 to 65 years
  • consulting in a gynecological-obstetrical service of one of the investigator center for a colposcopy reflex after an abnormal cytology dating of less than 6 months and more than 1 month
  • signature of the informed consent
  • affiliated to Social Security

Exclusion Criteria:

  • women vaccinated against HPV
  • women who received a treatment for a cervical pathology followed by a normal
  • women with a known positive HIV test
  • women suffering from a chronic pathology that generate immunosuppression
  • Women currently treated with immunosuppressors
  • Women treated with corticoids currently or dating of less than 6 months
  • protected by law
  • pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: arm 1
all patients included in IDAHO study
Other: all patients included in IDAHO study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence of high-risk papillomavirus in the analysis of cervical smear
Time Frame: during 36 months after inclusion
during 36 months after inclusion
integration of genome of high-risk papillomavirus detected in cervical smear according molecular combing
Time Frame: during 36 months after inclusion
during 36 months after inclusion
presence and severity of cervical lesion according to results of cervical smear, colonoscopy and histological analysis
Time Frame: during 36 months after inclusion
during 36 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

December 17, 2018

Study Completion (ACTUAL)

December 17, 2019

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (ESTIMATE)

August 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI15088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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